In Part 1, we are determining the maximum tolerable dose (MTD) of LB-100 administered alone; in Part 2, we are determining the MTD of LB-100 combined with the widely used anti-cancer drug, docetaxel, as the basis for designing studies of LB-100 plus docetaxel in Phase II trials in solid tumors.

Phase Two: More patients are recruited - between 25 and 50 - and tests are done to see what effect the drug has and to establish the MTD - maximum tolerable dose - and compare its efficacy with current medication.

Kovach concluded, "The primary goal of our current Phase I trial is to determine the maximum tolerable dose (MTD) of LB-100 in combination with docetaxel and then to test to what extent LB-100 improves the efficacy of docetaxel against common solid tumors in Phase 2 trials.

Patients received a single-session dose escalation to estimate their maximum tolerable dose (MTD) followed by an 8-week open-label daily course of SLIT using a metered dosing device specifically designed for the trials.

The Phase I trial will evaluate the safety and maximum tolerable dose of sublingual-oral immunotherapy in patients with confirmed Timothy grass pollen allergy and history of at least one systemic reaction to subcutaneous immunotherapy.

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